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ASTM F1441-03

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Standard Specification for Soft-Tissue Expander Devices

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1.1 This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed.

1.2 Limitations:

1.2.1 This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification.

1.2.2 This specification applies, in part, to combination "expander/mammary" devices as classified in Section 4.

1.3 The values stated in SI units are to be regarded as standard, values in parentheses are for information only.

1.4 The following statement pertains only to the test methods and requirements portion, Section 9, of this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.


This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification. The device shall be classified as: Type I; Type II; and Type III. Biocompatibility, tensile set, breaking force, tubing shell junction, injection port competence, overexpansion, tubing length adapter strength, needle stop penetration, and fused or adhered joints tests shall be performed to conform with the specified requirements.


SDO ASTM: ASTM International
Document Number F1441
Publication Date April 10, 2003
Language en - English
Page Count 5
Revision Level 03
Supercedes
Committee F04.32
Publish Date Document Id Type View
April 10, 2003 F1441-03 Revision
Oct. 1, 2022 F1441-03R22 Reaffirmation
Oct. 1, 2014 F1441-03R14 Reaffirmation
April 1, 2009 F1441-03R09 Reaffirmation
Oct. 10, 1998 F1441-92R98 Reaffirmation
Dec. 15, 1992 F1441-92R02 Reaffirmation